GHP Chapter 1 Quality Management The EU guide describes QA, GMP and QC as being inter-related and includes in chapter 1 definitions of the three terms.
Quality Assurance “Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the total sum of the organised arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors” GMP “Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification” Quality control “Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory”
Chapter 2 Personnel Any good Quality Management system is reliant on people. Chapter 2 requires that Pharmaceutical manufacturers have available sufficient numbers of suitably qualified personnel to allow them to carry out the allotted tasks in a manner consistent with the requirements of GMP. All personnel must be trained in the basic requirements of GMP and be provided with sufficient additional training commensurate with their duties and responsibilities. All personnel must adhere to suitable standards of personal hygiene and report any illness or infection if required to enter clean areas.
Chapter 3 Premise and Equipment
Chapter 3 includes requirements for the location, design, construction, and layout of premises to be used for the manufacture, storage and testing of pharmaceutical product, as well as their ongoing maintenance, cleaning, usage and security. Buildings and the essential supporting services, heating, lighting, ventilation must be designed, constructed and maintained so as to minimise the risk of external contamination and cross contamination of the pharmaceutical product, starting materials or intermediate during manufacture and storage.
Buildings must be laid out in such a way as to facilitate the logical flow of material through from starting material to finished pharmaceutical product and must be of sufficient capacity to allow clear segregation of different products during manufacture and storage. Personnel access to manufacturing, storage and laboratory areas must be controlled and suitable separate washing and changing areas provided. Manufacture of Antibiotics and cytotoxics and other high potency products should be carried out in facilities well separated from general pharmaceutical manufacturing areas. Chapter 3 includes requirements for the design, construction, location and installation of manufacturing equipment and also maintenance and cleaning of all such equipment.
Chapter 4 Documentation Good documentation is an essential part of any Quality management system, organisations rely on documentation to provide clear instructions and ensure that procedures are followed; clear and concise records are maintained of all aspects of the manufacturing and testing operations.Documents must be clear, orderly, unambiguous and laid out so as to facilitate checking and review. All documents must be reviewed and approved by appropriately qualified responsible persons.Chapter 4 defines four types of required documents.
Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Specifications must clear and unambiguous and must be written for Raw Materials and Packaging materials, Finished Products as well as Intermediate or bulk product. Specifications must encompass all characteristics of the material that may impact on the final quality of the pharmaceutical product and must include physical, chemical and microbiological characteristics and any special storage and handling requirements necessary to preserve product quality. Manufacturing Formulae, Processing and Packaging Instructions state all the starting materials used including quantities and provide detailed stepwise instructions for all processing and packaging operations and the records to be made at each stage: including any special storage or handling requirements. They may reference Standard Operating Procedures for any manufacturing and testing equipment used and standard procedures for sampling testing and cleaning operations. Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, and equipment operation. Written and approved procedures must be available for all operations from ordering of starting materials through to dispatch of finished product including all supporting processes such as validation, calibration and maintenance. Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent to the quality of the final product. Clear legible records must be kept of all activities carried out which may impact the quality of the pharmaceutical product including ordering and receipt of materials, all manufacturing operations, sampling and testing at all stages of manufacture, and distribution of finished product; to include supporting processes such as training, validation, cleaning, maintenance and calibration, customer complaints and returns.
Chapter 5 Production Production operations must be performed by competent persons and follow defined written procedures and comply with the principles of GMP and the requirements of the relevant marketing authorisation. All steps in the manufacturing process including:
Purchase of starting materials
Storage of starting materials, intermediates and product
Manufacture
Cleaning of equipment
Packaging and labelling
Sampling and testing
Distribution of product
Must be in accordance with written procedures and fully documented, including documentation and approval of any and all deviations from the written procedures. Materials must be stored and processed under conditions which minimise the risk of deterioration, damage or contamination of the starting materials, intermediates or finished product. All manufacturing processes must be validated.
Chapter 6 Quality Control Chapter 6 includes requirements for Documentation, Sampling and testing as well as the retention of records, and reference samples. Quality control covers sampling, specifications and testing of starting materials, packaging materials, intermediates and finished goods and also the documentation and release procedures to ensure that materials cannot be released before they have been judged to be satisfactory. The Quality Control department must be independent from manufacturing and must be involved in all decisions which may affect product quality. Quality Control Laboratories must have the necessary personnel, premises and equipment to allow them to perform all tasks needed to support the manufacturing operations. As of June 2006, manufacturers must implement and maintain an on-going program of stability testing, in accordance with ICH Q1 recommendations to monitor the manufactured product over its shelf-life and demonstrate that the product remains within specification when stored under the labelled conditions for the duration of the shelf-life. Laboratory documentation must include:
Specifications
Sampling and test methods with supporting method validations including methods for in-process tests which may be performed in the manufacturing area
Equipment Qualification, calibration and maintenance procedures and records
Analytical reports and results
Stability protocols and results
Chapter 7 Contract Manufacture and Analysis Chapter 7 defines the responsibilities of contract giver and contract acceptor in cases where manufacture and or analysis is performed. Contract manufacture may only be performed by manufacturers holding a manufacturing authorisation.The contract must be drawn up to unambiguously define the responsibilities of the contract giver and contract acceptor and must ensure that all manufacture and analysis is performed in accordance with the requirements of GMP. In particular, contract laboratories must be aware that they will be subject to inspection by regulatory authorities.
Chapter 8 Complaints and Product Recall Complaints All complaints must be investigated in accordance with written procedures by a designated individual, usually the person responsible for Quality Control, and any necessary corrective and preventative actions implemented.All complaints must be reviewed regularly for any indication of recurring problems. Recalls Recalls must be carried out in accordance with approved written procedures which have been evaluated and their effectiveness demonstrated. Sufficient records of shipment and distribution of product must be maintained to allow an effective recall to be carried out promptly. All national Regulatory Authorities must be informed immediately in the event of a recall of a product which is, or is suspected to be, defective. The Qualified Person must be aware of all complaints and resultant investigations and all recalls
Chapter 9 Self Inspection Pharmaceutical manufacturers are required to carry out regular Internal Audits or Self-inspections to monitor continuing compliance with the requirements of GMP.All sections of the organisation having an impact on product quality must be inspected at regular intervals by an independent and competent person, the results recorded and any necessary corrective actions implemented.
Chapter 1 Quality Management
The EU guide describes QA, GMP and QC as being inter-related and includes in chapter 1 definitions of the three terms.
Quality Assurance “Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the total sum of the organised arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors”
GMP “Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification”
Quality control “Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory”
Chapter 2 Personnel
Any good Quality Management system is reliant on people. Chapter 2 requires that Pharmaceutical manufacturers have available sufficient numbers of suitably qualified personnel to allow them to carry out the allotted tasks in a manner consistent with the requirements of GMP. All personnel must be trained in the basic requirements of GMP and be provided with sufficient additional training commensurate with their duties and responsibilities. All personnel must adhere to suitable standards of personal hygiene and report any illness or infection if required to enter clean areas.
Chapter 3 Premise and Equipment
Chapter 3 includes requirements for the location, design, construction, and layout of premises to be used for the manufacture, storage and testing of pharmaceutical product, as well as their ongoing maintenance, cleaning, usage and security.
Buildings and the essential supporting services, heating, lighting, ventilation must be designed, constructed and maintained so as to minimise the risk of external contamination and cross contamination of the pharmaceutical product, starting materials or intermediate during manufacture and storage.
Buildings must be laid out in such a way as to facilitate the logical flow of material through from starting material to finished pharmaceutical product and must be of sufficient capacity to allow clear segregation of different products during manufacture and storage.
Personnel access to manufacturing, storage and laboratory areas must be controlled and suitable separate washing and changing areas provided.
Manufacture of Antibiotics and cytotoxics and other high potency products should be carried out in facilities well separated from general pharmaceutical manufacturing areas.
Chapter 3 includes requirements for the design, construction, location and installation of manufacturing equipment and also maintenance and cleaning of all such equipment.
Chapter 4 Documentation
Good documentation is an essential part of any Quality management system, organisations rely on documentation to provide clear instructions and ensure that procedures are followed; clear and concise records are maintained of all aspects of the manufacturing and testing operations.Documents must be clear, orderly, unambiguous and laid out so as to facilitate checking and review. All documents must be reviewed and approved by appropriately qualified responsible persons.Chapter 4 defines four types of required documents.
Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Specifications must clear and unambiguous and must be written for Raw Materials and Packaging materials, Finished Products as well as Intermediate or bulk product. Specifications must encompass all characteristics of the material that may impact on the final quality of the pharmaceutical product and must include physical, chemical and microbiological characteristics and any special storage and handling requirements necessary to preserve product quality.
Manufacturing Formulae, Processing and Packaging Instructions state all the starting materials used including quantities and provide detailed stepwise instructions for all processing and packaging operations and the records to be made at each stage: including any special storage or handling requirements. They may reference Standard Operating Procedures for any manufacturing and testing equipment used and standard procedures for sampling testing and cleaning operations.
Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, and equipment operation. Written and approved procedures must be available for all operations from ordering of starting materials through to dispatch of finished product including all supporting processes such as validation, calibration and maintenance.
Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent to the quality of the final product. Clear legible records must be kept of all activities carried out which may impact the quality of the pharmaceutical product including ordering and receipt of materials, all manufacturing operations, sampling and testing at all stages of manufacture, and distribution of finished product; to include supporting processes such as training, validation, cleaning, maintenance and calibration, customer complaints and returns.
Chapter 5 Production
Production operations must be performed by competent persons and follow defined written procedures and comply with the principles of GMP and the requirements of the relevant marketing authorisation. All steps in the manufacturing process including:
- Purchase of starting materials
- Storage of starting materials, intermediates and product
- Manufacture
- Cleaning of equipment
- Packaging and labelling
- Sampling and testing
- Distribution of product
Must be in accordance with written procedures and fully documented, including documentation and approval of any and all deviations from the written procedures.Materials must be stored and processed under conditions which minimise the risk of deterioration, damage or contamination of the starting materials, intermediates or finished product.
All manufacturing processes must be validated.
Chapter 6 Quality Control
Chapter 6 includes requirements for Documentation, Sampling and testing as well as the retention of records, and reference samples. Quality control covers sampling, specifications and testing of starting materials, packaging materials, intermediates and finished goods and also the documentation and release procedures to ensure that materials cannot be released before they have been judged to be satisfactory. The Quality Control department must be independent from manufacturing and must be involved in all decisions which may affect product quality.
Quality Control Laboratories must have the necessary personnel, premises and equipment to allow them to perform all tasks needed to support the manufacturing operations.
As of June 2006, manufacturers must implement and maintain an on-going program of stability testing, in accordance with ICH Q1 recommendations to monitor the manufactured product over its shelf-life and demonstrate that the product remains within specification when stored under the labelled conditions for the duration of the shelf-life.
Laboratory documentation must include:
Chapter 7 Contract Manufacture and Analysis
Chapter 7 defines the responsibilities of contract giver and contract acceptor in cases where manufacture and or analysis is performed. Contract manufacture may only be performed by manufacturers holding a manufacturing authorisation.The contract must be drawn up to unambiguously define the responsibilities of the contract giver and contract acceptor and must ensure that all manufacture and analysis is performed in accordance with the requirements of GMP. In particular, contract laboratories must be aware that they will be subject to inspection by regulatory authorities.
Chapter 8 Complaints and Product Recall
Complaints
All complaints must be investigated in accordance with written procedures by a designated individual, usually the person responsible for Quality Control, and any necessary corrective and preventative actions implemented.All complaints must be reviewed regularly for any indication of recurring problems.
Recalls
Recalls must be carried out in accordance with approved written procedures which have been evaluated and their effectiveness demonstrated. Sufficient records of shipment and distribution of product must be maintained to allow an effective recall to be carried out promptly. All national Regulatory Authorities must be informed immediately in the event of a recall of a product which is, or is suspected to be, defective.
The Qualified Person must be aware of all complaints and resultant investigations and all recalls
Chapter 9 Self Inspection
Pharmaceutical manufacturers are required to carry out regular Internal Audits or Self-inspections to monitor continuing compliance with the requirements of GMP.All sections of the organisation having an impact on product quality must be inspected at regular intervals by an independent and competent person, the results recorded and any necessary corrective actions implemented.
Reading articles & links:
GMP in food industry
Current Good Manufacturing Practices (CGMPs)
Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist
GMP ARTICLES
Process and control
GMP FOR JUICE:
Aloe Complete - Good Manufacturing Practices
CANNED FRUIT JUICES
GMP FOR YOGHURT:
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